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Clinical Trial NCT07467343 for Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Ain Shams UniversitySilodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial Phase 4 140 Randomized Crossover Design
Clinical Trial NCT07467343 is designed to study Treatment for Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on March 22, 2026 until the study accrues 140 participants. Led by Ain Shams University, this study is expected to complete by October 22, 2026. The latest data from ClinicalTrials.gov was last updated on March 16, 2026.
Brief Summary
The goal of this randomized crossover clinical trial is to compare the efficacy and safety of Silodosin versus Tamsulosin in patients with moderate to severe lower urinary tract symptoms due to Benign Prostatic Hyperplasia. The main questions it aims to answer are:
Does Silodosin provide superior improvement in symptom scores (IPSS) compared to Tamsulosin?
Is there a difference in safety profile and adverse events ...
Show MoreOfficial Title
: Efficacy of Silodosin Versus Tamsulosin in Patients With Moderate to Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Randomized Crossover Clinical Trial
Conditions
Benign Prostatic HyperplasiaLower Urinary Tract SymptomsOther Study IDs
- FMASU MS 151/2026
NCT ID Number
Start Date (Actual)
2026-03-22
Last Update Posted
2026-03-16
Completion Date (Estimated)
2026-10-22
Enrollment (Estimated)
140
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Silodosin
Tamsulosin
Alpha-1 Adrenergic Antagonists
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
International Prostate Symptom Score
Uroflowmetry
Postvoid Residual Urine
Tamsulosin
Alpha-1 Adrenergic Antagonists
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
International Prostate Symptom Score
Uroflowmetry
Postvoid Residual Urine
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorSilodosin followed by Tamsulosin Participants assigned to this sequence will receive silodosin 8 mg oral capsules once daily for 4 weeks, followed by tamsulosin 0.4 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events. | Silodosin Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. Tamsulosin Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. |
Active ComparatorTamsulosin followed by Silodosin Participants assigned to this sequence will receive tamsulosin 0.4 mg oral capsules once daily for 4 weeks, followed by silodosin 8 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events. | Silodosin Silodosin 8 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. Tamsulosin Tamsulosin 0.4 mg oral capsule administered once daily for 4 weeks during the assigned treatment period. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in International Prostate Symptom Score | Change in total International Prostate Symptom Score from baseline to the end of each 4-week treatment period to compare symptom improvement with silodosin and tamsulosin in patients with benign prostatic hyperplasia-associated lower urinary tract symptoms. The International Prostate Symptom Score ranges from 0 to 35, with higher scores indicating more severe symptoms. | Baseline, Week 4, and Week 8 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Postvoid Residual Urine Volume | Change in postvoid residual urine volume measured by pelvi-abdominal ultrasound from baseline to the end of each 4-week treatment period. | Baseline, Week 4, and Week 8 |
Change in Peak Urinary Flow Rate | Change in peak urinary flow rate (Qmax) measured by uroflowmetry from baseline to the end of each 4-week treatment period. | Baseline, Week 4, and Week 8 |
Change in Quality of Life Score | Change in quality of life score assessed using the quality of life item of the International Prostate Symptom Score (IPSS) questionnaire. The IPSS quality of life question is scored from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." Higher scores indicate worse quality of life related to urinary symptoms. | Baseline, Week 4, and Week 8 |
Change in International Index of Erectile Function-5 Score | Change in erectile function assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire. The IIEF-5 score ranges from 5 to 25, with higher scores indicating better erectile function. | Baseline, Week 4, and Week 8 |
Incidence of Ejaculatory Dysfunction | Number of participants reporting ejaculatory dysfunction during each treatment period. | Throughout Week 1 to Week 8 |
Incidence of Dizziness | Number of participants reporting dizziness during each treatment period. | Baseline to Week 4 and Week 4 to Week 8 |
Incidence of Hypotension | Number of participants reporting or developing hypotension during each treatment period. | Baseline to Week 4 and Week 4 to Week 8 |
Incidence of Ejaculatory Dysfunction | Number of participants reporting ejaculatory dysfunction during each treatment period. | Baseline to Week 4 and Week 4 to Week 8 |
Incidence of Gastrointestinal Adverse Events | Number of participants reporting gastrointestinal adverse events during each treatment period. | Baseline to Week 4 and Week 4 to Week 8 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
Male
- Male participants aged 50 years or older
- Diagnosis of benign prostatic hyperplasia with moderate to severe lower urinary tract symptoms
- International Prostate Symptom Score of 8 or greater
- Prostate volume of 30 mL or greater
- Able and willing to provide informed consent
- No active treatment for benign prostatic hyperplasia during the month before enrollment
- Suspected neurogenic bladder
- Bladder neck contracture
- Urethral stricture
- Chronic urinary retention
- Prostate cancer
- Urinary bladder stones
- Urinary bladder tumors
- History of prostate surgery
- Known allergy, hypersensitivity, or contraindication to silodosin or tamsulosin
- Current use of alpha-adrenergic blocker therapy
- Severe renal impairment with creatinine clearance less than 30 mL/min
- Severe hepatic impairment
- Concomitant use of strong cytochrome P450 3A4 inhibitors, including ketoconazole, clarithromycin, itraconazole, or ritonavir
Ain Shams University344 active studies to exploreStudy Responsible Party
Ahmed Mokhtar kamal mustafa, Principal Investigator, Resident of Urology, Ain Shams University
Study Central Contact
Contact: Ahmed M Kamal, MBBCh, 01200271186, [email protected]
1 Study Locations in 1 Countries
Ain Shams University Hospitals, Urology Outpatient Clinic, Cairo, 11566, Egypt
Ahmed Kamal Mokhtar, MBBCh, Contact, 01200271186, [email protected]